Growth Hormone Dynamics and Cardiac Steatosis in HIV

• ClinicalTrials.gov Identifier: NCT03826160
• Recruitment Status: Recruiting
• First Posted: February 1, 2019
• Last Update Posted: August 14, 2019
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Steven K. Grinspoon, MD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: January 30, 2019
• First Posted Date: February 1, 2019
• Last Update Posted Date: August 14, 2019
• Actual Study Start Date: January 30, 2019
• Estimated Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2019)

Intramyocardial lipid content [ Time Frame: 6 months ]

Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 30, 2019)

Circumferential diastolic strain rate [ Time Frame: 6 months ]

Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Growth Hormone Dynamics and Cardiac Steatosis in HIV
• Official Title: Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
• Brief Summary: Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

blood samples for subsequent processing

• Sampling Method: Non-Probability Sample
• Study Population: HIV patients, age 40-70 years old, with abdominal fat accumulation

Condition

• Human Immunodeficiency Virus
• Lipodystrophy
• Cardiac Disease

• Intervention: Not Provided

Study Groups/Cohorts

• Tesamorelin
  Individuals who plan to initiate tesamorelin clinically
• No Treatment
  Individuals who decline to initiate tesamorelin despite a clinical indication

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 30, 2019): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 30, 2021
• Estimated Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Men and women, ages 40-70 years
• Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
• Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
• Indication for tesamorelin per clinical judgment

Exclusion Criteria:

• CD4 < 100 cells/mm3 or HIV viral load > 400 copies/mL
• Current active AIDS-defining illness
• History or symptoms consistent with heart failure
• Standard contraindications to MRI including severe allergy to gadolinium
• Glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 within one month of MRI study
• Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
• HbA1c > 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
• Change in statin therapy within the past 3 months
• Chronic corticosteroid use except intermittent topic steroid creams or inhalers
• Pregnancy or breastfeeding

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Lindsay T Fourman, MD; 617-643-4590; lfourman@partners.org

Contact: Steven Grinspoon, MD; 617-724-9109; sgrinspoon@mgh.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03826160
• Other Study ID Numbers: 2018P001792
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Steven Grinspoon, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: August 2019